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临床试验/NCT04877418
NCT04877418已完成不适用

Tele-rehabilitation Through Constraint Induced Movement Therapy (TeleCIMT) at Recovering the Function of the Upper Limb and Quality of Life

Universidad de La Frontera1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Upper limb function in patients after stroke.

研究概览

简要总结

The current pandemic scenario is immensely challenging for healthcare professionals. Telerehabilitation,is a promising option that benefited many people, allowing continuity of therapeutic processes and promoting the admission of people without prior access to rehabilitation programs. This modality has shown comparable results with conventional rehabilitation strategies, applied in patients with neurological pathologies. However, the modalities applied and the quality of the studies are insufficient to establish their real benefits and effectiveness.

Strategies such as CIMT, have been shown to be effective in improving upper limb function and restoring quality of life in stroke survivors. However, there is little evidence on its effectiveness when administered under telerehabilitation modality.

详细描述

Objective To determine if movement-induced restriction therapy, delivered through telerehabilitation (TeleCIMT), recovers function and improves quality of life in patients with brachial sequelae, after a stroke.

Methodology A prospective, single-group experimental study will be conducted. The sample will be of an intentional type, selected according to meeting the inclusion criteria. Each participant will be evaluated three times, at the beginning, middle and end of the intervention using TeleCIMT. The evaluation scales to be used will be Motor Activity Log-30 (MAL-30) and Action Research Arm for function and ECVI-38 scale for quality of life. The difference between these measurements in each patient (change score) will express the progress (or setback) obtained through this modality of intervention via telerehabilitation. Specifically, the effects of the TeleCIMT will be examined by one-factor within-subject analysis of variance (ANOVA) using time (T1, T2, and T3) as the independent variable and the recovery measures as dependent variables. In all analyzes, results with p values less than or equal to 0.05 will be considered statistically significant.

Expected results Through this proposal, the aim is to promote a line of research that allows the development of scientific evidence in the area of telerehabilitation in subjects with neurological pathologies. This information will benefit numerous professionals, promoting timely access to rehabilitation, providing continuity in therapeutic processes and reversing levels of disability due to neurological pathologies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 30 and 80 years.
  • Who present a single stroke event confirmed by CT,
  • Between 5 and 14 points on the NIHSS Scale
  • Who have the ability to sit independently.
  • Who can follow simple instructions (score greater than 13 on the Mini Menta)l.
  • <2 points on the Modified Ashworth Scale on elbow and wrist
  • <4 points on the Visual Analog Scale on shoulder.
  • That they can perform a functional test of 20 ° of wrist extension and 10 ° of finger extension (take and drop a cloth with the affected hand).

排除标准

  • Severe cognitive impairment (aphasia, attention deficit, reasoning or memory disorders).
  • Severe sensory impairment (visual-auditory).
  • Orthopedic limitation (use of a cane).

研究组 & 干预措施

TeleCIMT group

Experimental

One month after baseline evaluations, patients will receive a 3-week program through TeleCIMT.

  • Task Oriented Repetitive Training
  • Use of the Affected Upper Extremity
  • Transfer Package

干预措施: TeleCIMT (Procedure)

结局指标

主要结局

Upper limb function in patients after stroke.

时间窗: 3 weeks

MAL: It is a structured interview, composed by 30 items, intended to examine how much and how well the subject uses their more-affected arm outside of the laboratory setting. During the test administration. participants should be told that they can give half scores (i.e., 0.5,1.5,2.5,3.5,4.5) if this is reflective of their ratings. ARAT: It is a performance test that evaluates the ability of the affected upper limb to pick up, move and grasp objects of different size, weight and shape in patients with cortical injury. It is composed of 19 items that examine grip, grip, clamp and gross movement. The total score ranges from 0 (none of the movements were performed) to 57 (all the movements were performed without difficulty). The application of both instruments will be carried out virtually according to standardized procedures.

次要结局

  • The quality of life of patients after stroke.(3 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ARLETTE PATRICIA DOUSSOULIN SANHUEZA

Principal Investigator

Universidad de La Frontera

研究点 (1)

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